Mycophenolic sodium - Generic Drug Details
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What are the generic sources for mycophenolic sodium and what is the scope of freedom to operate?
Mycophenolic sodium
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, and Novartis, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.Eighteen suppliers are listed for this compound.
Summary for mycophenolic sodium
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 13 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 21 |
DailyMed Link: | mycophenolic sodium at DailyMed |
Recent Clinical Trials for mycophenolic sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AstraZeneca | Phase 3 |
University Hospital, Tours | Phase 4 |
Lee's Pharmaceutical Limited | Phase 4 |
Pharmacology for mycophenolic sodium
Drug Class | Antimetabolite Immunosuppressant |
Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MYFORTIC | Delayed-release Tablets | mycophenolic sodium | 180 mg | 050791 | 1 | 2009-06-03 |
MYFORTIC | Delayed-release Tablets | mycophenolic sodium | 360 mg | 050791 | 1 | 2009-02-02 |
US Patents and Regulatory Information for mycophenolic sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Biocon Pharma | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 217031-002 | Nov 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Concord Biotech Ltd | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 211173-002 | Dec 13, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wanbang Biopharms | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 216637-001 | May 29, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for mycophenolic sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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